NCT05077683

Brief Summary

APERITIF is a prospective randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing the "FRENCHIE" registry, a French multicenter prospective observational study granted by "ANR-RHU Grand Emprunt", in which all consecutive patients admitted within 48 hours after symptom onset in a cardiac Intensive Care Unit (ICU) for an acute myocardial infarction (AMI) are included (NCT04050956). Among them, eligible Patients for "APERITIF" will be randomized into two groups: Dual Anti-Platelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, prescribed as soon as possible after admission and completion of the initial percutaneous coronary intervention/angiography procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

October 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

September 27, 2021

Last Update Submit

July 8, 2024

Conditions

Myocardial Infarction, AcuteLeft Ventricular Thrombus

Keywords

Myocardial infarctionLeft ventricular thrombus

Outcome Measures

Primary Outcomes (1)

  • Rate of thrombus between the two arms

    The main objective of this randomized trial is to determine whether, in anterior AMI patients (e.g., large necrosis area), the use of rivaroxaban 2.5mg twice daily in addition to DAPT (dual antiplatelet therapy) will reduce LV thrombus formation, compared with the use of DAPT alone (current practice). The primary endpoint is the presence of Left Ventricular (LV) thrombus at 1-month, as detected by the validated delayed enhancement (Cardiovascular Magnetic Resonance) CMR method

    1 month

Secondary Outcomes (5)

  • Description of the thrombus

    1 month

  • Rate of bleeding events

    1 month

  • Rate of major adverse cardiac events (MACE) at 1 month

    1 month

  • Rate of major adverse cardiac events (MACE) at 1 year

    1 year

  • Rate of antithrombotic using

    1 year

Study Arms (2)

DAPT

ACTIVE COMPARATOR

aspirin (≤100mg per day) and P2Y12 inhibitors (i.e. clopidogrel 75mg per day or ticagrelor 90mg twice a day), as per current guidelines

Drug: DAPT strategy

DAPT + Direct Oral AntiCoagulants (DOAC)

EXPERIMENTAL

aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily) and rivaroxaban 2.5mg twice daily.

Drug: Rivaroxaban 2.5 MG [Xarelto]Drug: DAPT strategy

Interventions

Rivaroxaban 2.5 MG [Xarelto]DRUG

Experimental group: usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) + rivaroxaban 2.5mg twice daily.

DAPT + Direct Oral AntiCoagulants (DOAC)
DAPT strategyDRUG

usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) +

DAPTDAPT + Direct Oral AntiCoagulants (DOAC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years;
  • Anterior STEMI (e.g., ST elevation above the J-point of ≥0.1 millivolt in ≥two contiguous leads or left bundle branch block) or very high-risk NSTEMI (e.g., dynamic ECG changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ECG changes or life-threatening ventricular arrhythmias) with echographic evidence of anterior wall motion abnormalities and, with a culprit lesion of the proximal or mid portion of the left anterior descending (LAD) on the coronary angiography;
  • No contraindication to CMR (e.g., claustrophobia, pacemaker or defibrillator not compatible);
  • Ability to provide written informed consent and willing to participate in 1-month follow-up period.
  • Affiliation of social security regime.

You may not qualify if:

  • Patients with cardiogenic shock (systolic blood pressure \<90 mmHg with clinical signs of low output or patients requiring inotropic agents);
  • Patients referred to surgery for coronary artery bypass grafting (CABG) or treatment of acute complications (e.g. ventricular septal rupture);
  • Patients treated with fibrinolytic therapy;
  • LV thrombus diagnosed before randomization using a transthoracic echocardiography;
  • Active major bleeding or major surgery within the last 30 days;High bleeding risk (patients considered at increased risk of bleeding during DAPT; e.g. PRECISE-DAPT score \>25; severe liver failure or Child Pugh class C);
  • Known history of intracranial hemorrhagic stroke or intra-cranial aneurysm;
  • Known history of peptic ulcer;
  • Known stroke (any type) within the last 30 days;
  • Known intolerance to aspirin, P2Y12 inhibitors, rivaroxaban and their excipients;
  • Patients with presence of malignant neoplasms at high risk of bleeding
  • Patients with hepatic impairment
  • According to the SmPC any contraindication to rivaroxaban, aspirin, clopidogrel, ticagrelor
  • Known intolerance to gadolinium chelates;
  • Chronic kidney disease (creatinine clearance (ClCr) \<30 mL/min);
  • Indication for anticoagulation (e.g. atrial fibrillation, mechanical valves, LV thrombus…);
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HEGP

Paris, France

Location

Related Publications (1)

  • Puymirat E, Soulat G, Fayol A, Mousseaux E, Montalescot G, Cayla G, Steg PG, Berard L, Rousseau A, Drouet E, Simon T, Danchin N; APERITIF study investigators. Rationale and design of the direct oral anticoagulants for prevention of left ventricular thrombus after anterior acute myocardial infarction (APERITIF) trial. Am Heart J. 2023 Dec;266:98-105. doi: 10.1016/j.ahj.2023.09.005. Epub 2023 Sep 14.

    PMID: 37716448DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Etienne PUYMIRAT

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 14, 2021

Study Start

October 10, 2021

Primary Completion

March 10, 2023

Study Completion

February 9, 2024

Last Updated

July 10, 2024

Record last verified: 2023-07

Locations

FR(1)